퓨어킨외용액 효능·효과
광고
퓨어킨외용액 복용법 (용법·용량)
퓨어킨외용액 부작용·주의사항
전체 9개 항목 펼치기/접기
1. 다음과 같은 사람은 이 약을 사용하지 말 것.
2. 다음 환자에는 신중히 투여할 것.
3. 다음과 같은 사람은 이 약을 사용하기 전에 의사, 치과의사, 약사와 상의할 것.
4. 다음과 같은 경우 이 약의 사용을 즉각 중지하고 의사, 치과의사, 약사와 상의할 것. 상담 시 가능한 한 이 첨부문서를 소지할 것.
5. 기타 이 약의 사용 시 주의할 사항
6. 임부 및 수유부에 대한 사용
7. 소아에 대한 사용
8. 과량투여 시 처치
9. 저장상의 주의사항
퓨어킨외용액 성분·함량
이 약 100mL 중 기준
| 성분 | 영문 | 분량 |
|---|---|---|
| 클린다마이신포스페이트 | Clindamycin Phosphate | 1.188 그램 |
📍 퓨어킨외용액 살 수 있는 내 주변 약국
전문의약품은 의사 처방전이 있어야 약국에서 받을 수 있습니다. 재고는 약국에 전화로 확인하세요.
🗺️ 지도에서 찾기🌐 해외(미국) 정보 — 클린다마이신포스페이트
미국 FDA·NLM 자료 · 2026-09-30 기준이 성분은 한국어 번역이 없습니다(검수 전 자동 번역 게시는 멈춰 두었습니다). 아래는 미국 FDA 원문입니다 — 원문 라벨(DailyMed).
미국에서 쓰이는 곳(적응증)
영어 원문 (미국 FDA 라벨)
products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. CLEOCIN PHOSPHATE products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibacterial drug-associated pseudomembranous colitis, as described in the BOXED WARNING , before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. Indicated surgical procedures should be performed in conjunction with antibacterial drug therapy. CLEOCIN PHOSPHATE is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below: Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis ), and Staphylococcus aureus. Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus , and anaerobes. Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical …
⚠️ 박스 경고(가장 강한 경고)
영어 원문 (미국 FDA 라벨)
Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN PHOSPHATE and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . Because CLEOCIN PHOSPHATE therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
쓰면 안 되는 경우
영어 원문 (미국 FDA 라벨)
This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
주요 경고·주의
영어 원문 (미국 FDA 라벨)
See BOXED WARNING . Clostridioides difficile -Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CLEOCIN PHOSPHATE, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Anaphylactic and Severe Hypersensitivity Reactions Anaphylactic shock and anaphylactic reactions have been reported ( see ADVERSE REACTIONS ) . Severe hypersensitivity reactions, including acute myocardial ischemia with or without myocardial infarction, and severe skin reactions such as toxic …
임신·특수 환자
영어 원문 (미국 FDA 라벨)
Pregnancy: Teratogenic effects In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities. Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Reproduction studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (2.1 and 1.1 …
미국 제품명 Cleocin Phosphate, XACIATO
미국 부작용 보고(FAERS)에 많이 나온 증상
미국 FDA에 접수된 이 성분 관련 보고 37,644건 가운데 많이 적힌 증상입니다. 보고 수는 약 때문이라는 증거가 아니며, 많이 쓰는 약일수록 많아집니다. 증상 이름의 한국어는 AI 번역(참고용)이라 영어 원어를 함께 적었습니다.
- 1 약효 없음drug ineffective3,169
- 2 약물 과민반응drug hypersensitivity3,052
- 3 설사diarrhoea2,510
- 4 발진rash2,310
- 5 오심nausea2,204
- 6 통증pain1,984
- 7 적응증 외 사용off label use1,868
- 8 피로fatigue1,725
- 9 호흡 곤란dyspnoea1,578
- 10 급성 신장 손상acute kidney injury1,542
- 11 발열pyrexia1,503
- 12 만성 신장병chronic kidney disease1,449
미국 리콜 기록
FDA 리콜(회수) 기록 15건 중 최근 5건 — 특정 회사·제조번호 제품의 회수로, 국내 제품과는 관계없을 수 있습니다.
- 2026.09.09 · 2등급 · Baxter Healthcare Corporation CGMP Deviations
- 2026.09.09 · 2등급 · Baxter Healthcare Corporation CGMP Deviations
- 2026.09.09 · 2등급 · Baxter Healthcare Corporation CGMP Deviations
- 2026.09.09 · 2등급 · Baxter Healthcare Corporation CGMP Deviations
- 2026.09.09 · 2등급 · Baxter Healthcare Corporation CGMP Deviations
출처: 미국 FDA openFDA(라벨·FAERS·리콜), 미국 국립의학도서관 RxNorm · DailyMed 원문 라벨. 한국어는 오픈드럭 서버 AI(gemma)가 자동 번역한 참고용(사람 검수 전)으로 오역이 있을 수 있으니 반드시 원문을 확인하세요.
허가 정보
- 품목기준코드
- 200811163
- 허가 구분
- 신고 · 완제의약품
- 상태
- 정상
- 위탁 제조
- (주)퍼슨
- 저장 방법
- 기밀용기, 실온(1-30℃)보관
- 사용 기간
- 제조일로부터 24 개월
- 포장 단위
- 30mL/병
- ATC 코드
- D10AF01
- 표준코드
- 8806476015904, 8806476015911, 8806476015928
- 최근 변경
- 2021.11.03
허가 변경 이력
- · 성상, 2021-11-03
- · 사용상주의사항변경(부작용포함), 2019-10-10
- · 제품명칭변경, 2014-07-25
- · 저장방법 및 유효기간(사용기간)변경, 2014-07-25
- · 사용상주의사항변경(부작용포함), 2014-07-25
원문: 식약처 의약품안전나라
